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OpenTrials
Completed

NCT Number: NCT02952521

Ovarian Tumor Biopsies to Study Response to Treatments

This is a research study to look at differences in tumor tissue from ovarian cancer patients that may help to determine response and resistance to treatments.

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Key information

About this study

Ovarian cancer participants will be asked to have two tumor biopsies during the research study. The first biopsy will be done prior to receiving the participants' assigned treatments as a part of their cancer care and the second biopsy will be done about 3-7 days after starting treatment. Participants who will undergo neoadjuvant treatment and then surgery, will also have their tumor tissue collected during surgery. Participants whose disease worsens while on treatment will also be asked to have an additional, optional tumor biopsy.

The tumor tissue samples will be studied to look at certain proteins and enzymes, including enzymes called kinomes, that may be important in determining response and resistance to the treatment that participants will receive as a part of their cancer care.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age ≥18 years.
  • Histological diagnosis of epithelial ovarian cancer
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
  • Life expectancy of greater than 3 months
  • Diagnosis of epithelial ovarian cancer undergoing chemotherapy as part of standard care or a clinical trial OR receiving a targeted therapy with a targeted agent
  • Must be agreeable to paired biopsies
  • Must have disease amenable to paired biopsy.
  • Ability to understand and the willingness to sign a written informed consent document.

Exclusion criteria

  • Any contraindication to biopsy
  • Need for anticoagulation that cannot be interrupted

Treatment and study plan

Blood draw

Procedure

CA125 and ctDNA

Tumor tissue biopsy

Procedure

Only collected at time of surgery if patient undergoes surgical debulking

Primary outcomes

  1. Pearson correlation for changes between kinome and CA125

    Time frame: 5 years

  2. Paired T-test for differences in kinome between responders and non-responders

    Time frame: 5 years

Sponsors and collaborators

Lead sponsor

University Health Network, Toronto

Other

Registry information

Official study title

Paired Biopsies to Develop a Cellular Signature

Important dates

Study start
2017
Primary completion
2021
Study completion
2021
First posted
Nov 2, 2016
Registry last updated
May 10, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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